Japan
Locally based project management capabilities and regulatory expertise
Japan continues to be one of the largest pharmaceutical markets in the world.
With an aging population of nearly 127 million, the Japanese market for prescription and non-prescription pharmaceuticals in 2020 was $107 billion, according to the Ministry of Health, Labor and Welfare (MHLW)'s Annual Pharmaceutical Production Statistics.
-
27
Years in Japan -
950+
Staff based in Japan -
125+
Full-service studies in the last five years
Choosing the right partner
In recent years, the Japanese drug and medical device approval authority, the Pharmaceuticals and Medical Devices Agency (PMDA), has modified its approval process, making it easier to bring new drugs to the market in Japan. Nevertheless, there are economic, cultural and regulatory challenges that make it critical to choose a CRO partner that is well-established in Japan, with the expertise and experience to provide guidance and solutions throughout the drug development process.
Strong heritage and growing
ICON is a global CRO, with a presence in Japan since 1996. We provide full geographic reach, to allow for the most efficient site monitoring. With over 950 staff in Tokyo, Osaka, and home-based, we deliver global and local capabilities to pharmaceutical, biotechnology, medical device and government and public health organisations. (Visit our Japanese language website)
Clinical and regulatory expertise
Our experts have extensive experience of supporting global and local pharmaceutical, biotechnology and medical device organisations in their clinical development programs. With deep therapeutic experience particularly in oncology, CNS and infectious diseases; excellent relationships with regulatory bodies such as the PMDA and a well-developed network with investigative sites, we break down the barriers of reaching your milestones.
Full range of services
ICON can provide you with a full range of clinical development services to support global, pan-Asia Pacific, and local trials in Japan. With locally based project management capabilities and regulatory expertise, you will get the insight, innovation and performance that will make a difference to cycle times and quality of data.
- Cardiac Safety Monitoring
- Clinical Operations (Phase 1 – 3)
- Study Start-up
- Regulatory Affairs
- Medical Writing
- Pharmacovigilance
- Real World Evidence / Post Marketing Studies and Surveillance
- Medical Devices and Diagnostics
- PMDA Regulatory and Strategic Consultancy
- Clinical Pharmacology
- Medical Imaging
- Decentralised & hybrid clinical trials
- ICCC (In Country Clinical Caretaker)
- Strategic Resourcing and FSP Services
Navigating the regulatory landscape in the US and Japan
This whitepaper from ICON’s data standards experts provides practical guidance to help sponsors navigate evolving FDA and PMDA submission requirements for clinical data, highlighting both differences and opportunities for harmonisation.
